16-Week Randomized Split-Face Efficacy Study of Cosmetic Formulations in Photoaged Pigmented Skin Subjects
Primary Purpose
Aging Problems, Pigmentation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cosmetic Formulations
Sponsored by
About this trial
This is an interventional treatment trial for Aging Problems focused on measuring cosmetic, ethnic skin, anti-aging, pigmentation
Eligibility Criteria
Inclusion Criteria:
- Be a female in general good health, based on medical history reported by the subject;
- From thirty (30) to sixty-five (65) years of age, inclusive;
- Fitzpatrick skin types IV, V or VI;
- Have mild to moderate skin tone evenness (a score of 3-6);
- Willing to avoid excessive solar or UV exposure including: minimizing direct sun exposure and avoiding tanning beds and sunless tanning products for the duration of the study;
- Willing to cleanse the face and remove all facial and all eye make-up prior to (or upon arrival) every study visit;
- Willing to use no other topical products on the face for the duration of the study except the assigned test product and the subject's regular brand(s) of non-medicated make-up products that do not contain salicylic acid, benzoyl peroxide, AHA's, retinol, or their analogs or derivatives;
- Willing to refrain from using exfoliating products for the duration of the study;
- Not make any changes to her usual skin care regimen while participating in this study, other than those required by the study protocol;
- Willing and able to follow all study instructions and adhere to study restrictions;
- Read and sign an IRB approved informed consent form after the nature of the study has been fully explained and all questions have been answered by site staff;
- Female subjects determined to be of child-bearing potential must indicate that they are not pregnant and/or lactating, nor do they intend to become pregnant during their study participation;
- Female subjects determined to be of child-bearing potential must agree to practice a medically acceptable form of birth control during the study;
Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include:
- Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring)
- Barrier methods of contraception (condom or diaphragm)
- Intrauterine device or system (IUD/IUS)
- Surgical sterilization (vasectomy, hysterectomy, tubal occlusion, uterine ablation)
- Abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence is not an acceptable method of contraception
Exclusion Criteria:
- Has participated in any other clinical facial use study within four (4) weeks from the start of the study;
- Has received any type of skin treatment or procedure in the past 3 (3) months including: chemical peels, microdermabrasion, injection of collagen or other filler, Botox® injections, or any treatment involving heat, light, or RF energy;
- Is currently under a physician's care for a medical problem that, in the opinion of the Investigator or his designee, could affect the subject's treatment response;
- Is nursing, pregnant, or planning a pregnancy during the course of this study;
- Has excessive facial hair, or scars which could interfere with study evaluation in the opinion of the Investigator;
- Is taking any prescription or over-the-counter medication that, in the opinion of the Investigator or his designee, could affect the subject's treatment response;
- Has any other condition that, in the opinion of the Investigator or his designee, could interfere with the subject's ability to use the treatment as instructed, alter treatment response, or affect their ability to complete the study.
Sites / Locations
Outcomes
Primary Outcome Measures
Skin Tone Unevenness
Using a 0-9 scale where 0= even tone and 9=severe blotchy hyperpigmentation. Subjects will be recruited with mild to moderate skin tone unevenness. The goal is to show improvements by dermatologist assessments and photography
Skin Firming
Using a non-invasive clinical instrument (Cutometer) skin elasticity will be measure of the facial cheek
Skin Moisture
Using a non-invasive clinical instrument (SkiCon) skin conductance will be measure of the facial cheek
Skin Oiliness
Using a non-invasive clinical instrument (Sebumeter) skin conductance will be measure of the facial cheek
Secondary Outcome Measures
Full Information
NCT ID
NCT05160103
First Posted
December 3, 2021
Last Updated
December 3, 2021
Sponsor
Avon Products, Inc.
Collaborators
University of Cape Town, Groote Schuur Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05160103
Brief Title
16-Week Randomized Split-Face Efficacy Study of Cosmetic Formulations in Photoaged Pigmented Skin Subjects
Official Title
16-Week Randomized Split-Face Efficacy Study of Cosmetic Formulations in Photoaged Pigmented Skin Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avon Products, Inc.
Collaborators
University of Cape Town, Groote Schuur Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to determine the efficacy of seven different formulations currently marketed and commercially available cosmetic products on skin tone evenness, post-inflammatory hyperpigmentation, and discrete pigmentation in females of Fitzpatrick skin types IV-VI.
Detailed Description
This is a single site, double-blind randomized, split face, efficacy study. All subjects will receive a cleanser, Day Cream/sunscreen, and two treatment products. The treatment products will be applied in a split face fashion including behind the ear.
Local volunteer subjects will be enrolled such that a total of eighty-four (84) subjects will complete the study; with 24 subjects completing in each treatment.
Each subject will receive a cleanser, Day Cream/sunscreen and two treatment products as per the randomization. Subjects will use the cleanser twice daily, Day Cream/sunscreen in the morning, and the treatment products as specified after cleansing in the evening, for a period of 16 weeks. Clinical assessments, non-invasive instrument measurements and photographs will be completed at baseline and weeks 4, 8, 12, and 16. Biopsies will be taken at baseline and Week 16.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging Problems, Pigmentation
Keywords
cosmetic, ethnic skin, anti-aging, pigmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single site, randomized, seven treatments, split face, efficacy study
Masking
ParticipantInvestigator
Masking Description
Products Codes A-G
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Cosmetic Formulations
Intervention Description
Topical emulsions containing anti-aging ingredients
Primary Outcome Measure Information:
Title
Skin Tone Unevenness
Description
Using a 0-9 scale where 0= even tone and 9=severe blotchy hyperpigmentation. Subjects will be recruited with mild to moderate skin tone unevenness. The goal is to show improvements by dermatologist assessments and photography
Time Frame
Every 4 weeks up to 16 weeks
Title
Skin Firming
Description
Using a non-invasive clinical instrument (Cutometer) skin elasticity will be measure of the facial cheek
Time Frame
Every 4 weeks up to 16 weeks
Title
Skin Moisture
Description
Using a non-invasive clinical instrument (SkiCon) skin conductance will be measure of the facial cheek
Time Frame
Every 4 weeks up to 16 weeks
Title
Skin Oiliness
Description
Using a non-invasive clinical instrument (Sebumeter) skin conductance will be measure of the facial cheek
Time Frame
Every 4 weeks up to 16 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-identifying females
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be a female in general good health, based on medical history reported by the subject;
From thirty (30) to sixty-five (65) years of age, inclusive;
Fitzpatrick skin types IV, V or VI;
Have mild to moderate skin tone evenness (a score of 3-6);
Willing to avoid excessive solar or UV exposure including: minimizing direct sun exposure and avoiding tanning beds and sunless tanning products for the duration of the study;
Willing to cleanse the face and remove all facial and all eye make-up prior to (or upon arrival) every study visit;
Willing to use no other topical products on the face for the duration of the study except the assigned test product and the subject's regular brand(s) of non-medicated make-up products that do not contain salicylic acid, benzoyl peroxide, AHA's, retinol, or their analogs or derivatives;
Willing to refrain from using exfoliating products for the duration of the study;
Not make any changes to her usual skin care regimen while participating in this study, other than those required by the study protocol;
Willing and able to follow all study instructions and adhere to study restrictions;
Read and sign an IRB approved informed consent form after the nature of the study has been fully explained and all questions have been answered by site staff;
Female subjects determined to be of child-bearing potential must indicate that they are not pregnant and/or lactating, nor do they intend to become pregnant during their study participation;
Female subjects determined to be of child-bearing potential must agree to practice a medically acceptable form of birth control during the study;
Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include:
Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring)
Barrier methods of contraception (condom or diaphragm)
Intrauterine device or system (IUD/IUS)
Surgical sterilization (vasectomy, hysterectomy, tubal occlusion, uterine ablation)
Abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence is not an acceptable method of contraception
Exclusion Criteria:
Has participated in any other clinical facial use study within four (4) weeks from the start of the study;
Has received any type of skin treatment or procedure in the past 3 (3) months including: chemical peels, microdermabrasion, injection of collagen or other filler, Botox® injections, or any treatment involving heat, light, or RF energy;
Is currently under a physician's care for a medical problem that, in the opinion of the Investigator or his designee, could affect the subject's treatment response;
Is nursing, pregnant, or planning a pregnancy during the course of this study;
Has excessive facial hair, or scars which could interfere with study evaluation in the opinion of the Investigator;
Is taking any prescription or over-the-counter medication that, in the opinion of the Investigator or his designee, could affect the subject's treatment response;
Has any other condition that, in the opinion of the Investigator or his designee, could interfere with the subject's ability to use the treatment as instructed, alter treatment response, or affect their ability to complete the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Musonda Machona, MD
Phone
+27(0)634328862
Email
musondamachona@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nonhlanhla P Khumalo, PhD
Phone
+27(0)214043376
Email
n.khumalo@uct.ac.za
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ardeshir Bayat, PhD
Organizational Affiliation
Professor & Co-Director, University of Cape Town
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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16-Week Randomized Split-Face Efficacy Study of Cosmetic Formulations in Photoaged Pigmented Skin Subjects
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